Ministry of Health says Brodies Knew the Rules
The Ministry of Health has responded to James Brodie & Company Ltd.’s press release about a shipment of pharmaceutical products being denied entry into Belize. The Ministry pointed out it informed stakeholders in November 2016 that in 2017 there would be a Statutory Instrument that required labeling and documentation of all pharmaceutical products to be in English and/or Spanish. Of all the companies that imported products in a different language, James Brodie and Company stood alone and continued to import the same products. This includes ZIOTIS which claimed to be coming from England but was from Turkey.
The Ministry said it wrote Brodies on June 21 informing them that any shipment that is on its way will not be allowed into the country unless they have been granted approval prior to its arrival. Brodies proceeded to import the container which showed that all product labels and patient leaflet information were in Turkish; no affixed English or Spanish labels were found. Also noted were changes in names, manufacturer, batch number, and expiry date. There was also a higher quantity than that declared on the invoice for importation. An undeclared product invoice also appeared on the shipment.
There were five shipments on hold since June 2018, however, the Ministry released four based on the company’s compromise that they will be submitting all necessary documentation, of which only one has been received. For the ZIOTIS shipment on hold, the Ministry continued its plea to return to its supplier due to the significant discrepancies, but it is regrettable to note that ZIOTIS could not accept the return even after these were flagged. At no time did Brodies clarify these discrepancies to the Ministry, moreover, provide any proof of authenticity and quality of the products.
The Ministry stresses that No pharmaceutical company has been authorized to re-label or re-package pharmaceuticals that are not in English and/or Spanish. There is also a procedure set in place for patients who wish to import their medication to the country and also for all those patients who bear a rare disease.
LOVEFM
Ministry Doubles Down On Blocking Turkish Meds
Brodies has gone public in its war with the Ministry of Health - and tonight, the Ministry is snapping back. The Ministry says that after it implemented new regulations requiring labelling only in English or Spanish for all medicines, it identified five pharmaceutical companies out of 37 that were importing products with labels in other languages. Four of those companies discontinued importation of these foreign language medicines, except for Brodies.
The Ministry says that - in spite of the regs - it has still found foreign language medicines on pharmaceutical shelves supplied by Brodies up to May, 2018.
And then in June 2018, Brodies went to the Ministry with a list of over 160 products that did not have the required english-spanish labels. The Ministry says it did not take any action on these because they were already in the country. Then later that month, Brodies requested importation for a shipment of medicines coming from Turkey, with a receipt from a supplier in England. That told the Ministry that it was not coming from England and this shipment was not granted importation approval.
Still, the Ministry says Brodies brought it in - despite warnings that it would not be allowed into the country. Indeed, when the shipment reached, all product labels and patient leaflet information were in Turkish. The Ministry says it met with Brodies to request that the shipment be returned to its supplier. But the supplier could not accept the return even after the products were flagged.
Brodies now says it will have to destroy the ninety thousand dollars worth of medicines - they say to the detriment of persons who need specific medicines.
The Ministry says there is a procedure set in place for patients who wish to import their medication to the country and also for all those patients who bear a rare disease.
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"They have a shipment from 5 different pharmaceutical companies. None of the companies that they had brought in met the requirements which means GMP, CPP, labels need to be in English and Spanish. Notwithstanding that, we managed to give them permission for four out of the five companies under the understanding that they are going to bring in the necessary documentation. That's two, three months ago; they still haven't brought it in. There is one particular company, a distributing company, ZIOTIS and I can mention that company, which it is all products are labelled in Turkish. We said we can't allow this shipment to come in. They were alerted of this from May of this year and we told them what the process was. I think what made it a little more complicated in that particular item is that once they sent us what it is that they were trying to bring into the country, when we did an inspection, a visual inspection of what was happening there on the ground, it didn't match. So the products that they said they were bringing in are not the products that we found when we went there: they had different expiry date, different batch number, different pharmaceutical company. So because we are unable to verify that in point of fact what it is that they are saying that they are bringing in is what they are bringing in and to safeguard people, the health of people, we have said to them we can't allow this to come in. We gave them the option of shipping it back; apparently the company doesn't want it to be returned to them, so Brodies is saying well what do we do. Well, the rule has been there for more than a year; it's not that I am going to bend it back for anybody. And it is applicable to everybody; no single company has been allowed to do that."
